A Guide to Implementing Primary Angioplasty - Since the publication of new national good practice guiadance on treatment of heart attack. NHS Improvement looked at the major issues and obstacles to implementing primary percutaneous coronary angioplasty (PPCI) services across England and all the learning has now been pulled together in a useful implementation guide.
The guide provides a brief overview of current provision of primary PCI, a discussion of the issues and some useful suggestions to assist in the planning and commissiong of primary PCI services.
(Published June 2009).
1. NHS
NHS Improvement
CANCER
DIAGNOSTICS
Heart Improvement
A Guide to Implementing
HEART Primary Angioplasty
STROKE
2. Contents
Foreword 3
Purpose of this document 4
Introduction 4
Background 5
Current provision of Primary PCI (PPCI) in the UK 6
Challenges in developing a PPCI service 6
Does every PCI centre need to provide 24/7 PPCI? 7
Does the size of a PCI centre affect patient outcomes? 8
Should a non 24/7 PCI centre perform any PPCI? 8
Commissioning a PPCI service 10
Help with implementation 14
Summary 14
Appendix 1 - Key studies in PPCI 15
Appendix 2 - PCI consensus meeting 16
Appendix 3 - Treatment options for STEMI 17
References 18
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3. A Guide to Implementing Primary Angioplasty 3
Foreword
In only six months since the publication of new national good practice
guidance on treatment of heart attack, NHS Improvement have looked
at the major issues and obstacles to rolling out primary percutaneous
coronary angioplasty (PCI) services across England and brought together
all their learning in this helpful commissioning guide.
The guide provides a brief overview of current provision of primary PCI,
a discussion of the issues and some useful suggestions to assist in the
planning and commissioning of primary PCI services.
I would like to thank Jim McLenachan, Sheelagh Machin and Carol Marley at NHS Improvement for
their work to support implementation of primary PCI services including their work on this document
and to thank all those in cardiac networks who have informed the production of this guide.
Professor Roger Boyle CBE
National Director for Heart Disease and Stroke
Department of Health
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4. 4 A Guide to Implementing Primary Angioplasty
Purpose of this document Introduction
In October 2008, the Government suggested a Evidence suggests that patients who have
rapid expansion of coronary angioplasty (Primary suffered a heart attack have a greater chance of
survival and recovery if they are treated in a
Percutaneous Coronary Intervention or PPCI) for
specialist centre that provides primary
treatment of heart attack patients in England
percutaneous coronary intervention (PPCI).
(1). NHS Improvement (formerly the Heart
Improvement Programme) was tasked with ‘SHA visions have sent a powerful message that
facilitating the national roll-out of PPCI for heart the most effective treatments should be
available for all NHS patients. Their plans for
attack patients. Initial discussions with a number
transforming treatment for heart attacks vividly
of cardiac networks revealed several obstacles
illustrate this’ (2).
that were common to all. The aim of this
document is to provide commissioners, strategic The final report of the National Infarct
health authorities (SHAs), cardiac networks, Angioplasty Project (NIAP) was published on
20th October 2008 (1). NIAP was an
primary care trusts (PCTs), hospital trusts and
observational study to test the feasibility of
ambulance trusts with a synopsis of the major
establishing coronary angioplasty (Percutaneous
issues involved in developing an equitable, high Coronary Intervention or PCI) as the initial
quality coordinated service for heart attack treatment (in place of thrombolysis) for heart
patients in line with the Lord Darzis’ attack patients across England. The key findings
recommendations and the requirements of of the NIAP study were as follows:
world class commissioning.
1. PPCI can be delivered within acceptable
treatment times in a variety of settings.
Its main purpose is to enable the effective
2. Direct admission to a cardiac catheter
commissioning of evidence based care by
laboratory is the preferred route of admission
providing a national assessment of need,
to achieve timely treatment. This shifts the
reviewing current service provision and the
onus of diagnosis onto the ambulance service
available evidence to aid local prioritisation and
and away from Accident and Emergency
the specification of services to be provided.
departments.
As a result of their findings, the overall conclusions of NIAP were:
1. national roll-out of PPCI is feasible over the next three years
2. the aim should be to achieve treatment times of 120 minutes or less
3. hybrid services offering daytime PPCI and out-of-hours thrombolysis are not
satisfactory
4. a PPCI service needs to be 24/7 and the procedures should be carried out in a
centre with a sufficiently high volume of cases to maintain and develop skills.
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5. A Guide to Implementing Primary Angioplasty 5
Background
In 2007, 77,373 PCI procedures were performed
in 98 PCI centres in the UK (3). PCI patients fall
into three main groups:
1. Patients with stable angina
These patients are referred by their general
practitioner to either a rapid access chest pain
clinic or a general cardiology clinic. They
generally undergo treadmill testing or some
other non-invasive assessment of ischaemia
followed by diagnostic coronary angiography as
a day patient procedure. If they have ongoing
symptoms, and suitable anatomy, they will be
referred for PCI. Current waiting times are
around 4-6 weeks; these are considered clinically
acceptable and are compatible with the 18 week
referral to treatment pathway provided the
waiting times for clinic appointment, non-
invasive testing and angiography, are reasonably transferred to the PCI centre for an angiogram
short. with follow-on PCI if required. Current clinical
guidelines suggest that PCI should be performed
2. Patients with non-ST elevation acute within 72 hours of admission. NSTEACS patients
coronary syndrome (NSTEACS) occasionally require immediate access to a
These patients are admitted acutely through an cardiac catheter lab because of haemodynamic
Accident and Emergency department into a instability, ongoing ischaemia or other co
cardiology (or sometimes general medical) ward. morbidities, but most can be treated during
They are treated initially with anti-platelet, daylight hours.
anticoagulant and anti-anginal drugs. If they
have raised cardiac markers (e.g. troponin), or 3. Patients with ST segment elevation
ongoing symptoms, indicating that they are at myocardial infarction (STEMI)
high risk of further events, they will usually Immediate PCI is now the preferred treatment
undergo angiography and be considered for (over thrombolysis) for patients presenting with
revascularisation, in the form of either PCI or ST segment elevation MI (STEMI) provided it can
coronary artery bypass graft (CABG). If they have be delivered within an appropriate timeframe.
been admitted to a hospital with on-site PCI, the These patients are taken directly to the PCI
angiogram and PCI will be carried out as a single centre for primary PCI. This should be performed
procedure. If admitted to a hospital without as soon as possible and preferably within 120
onsite PCI, the angiogram may be carried out at minutes of the patient first summoning medical
the admitting hospital with onward referral to help. Primary PCI, therefore, mandates 24 hour
the PCI centre. Alternatively, patients may be access to the cardiac catheter lab.
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6. 6 A Guide to Implementing Primary Angioplasty
Current provision of Primary PCI
(PPCI) in the UK
The current provision of PPCI in the UK shows
huge geographical variation. In 2007-8, 27%
of STEMI patients in England and Wales were
treated with PPCI but the PPCI rates ranged
from almost 100% in London and The Black
Country to less than 10% in 13 of the 28
cardiac networks in England (4). In some areas, Currently, the NIAP guidance is to aim for a time
PPCI may be offered only on a 9-5 Monday to to treatment with PCI within 120 minutes of the
Friday basis with patients receiving thrombolysis patient calling for help.
at all other times. According to the BCIS Audit
The challenge in developing a PPCI service,
of 2007, only 22 of the 98 British PCI centres
therefore, is to ensure that most patients, at
offered a 24/7 service for PPCI (3).
whatever time they present and wherever they
present, undergo PPCI within 120 minutes of
Challenges in developing a PPCI service
first medical contact. This involves collaboration
Patients have heart attacks at all times of the between the ambulance service, the cardiac
day and night. To be effective, all treatment, departments, the cardiac catheter labs and the
whether thrombolysis or PPCI, should be Accident and Emergency departments. It is likely
provided as quickly as possible. The key studies that there will be individual patients where the
of PPCI are summarised in appendix 1. PPCI has 120 minutes timeline will be difficult to meet;
been shown to be significantly better than for most regions of the country, however, such
thrombolysis in preventing death, recurrent patients represent a small minority and should
myocardial infarction and stroke when both not obstruct clear improvements in systems of
treatments are administered at the same time. care. Where the time delay for an individual
The issue, therefore, is at what timepoint does patient is likely to be significantly greater than
delayed PPCI become less effective than 120 or 150 minutes, then pre-hospital
thrombolysis? Published data (see appendix 1) thrombolysis should be considered but the
suggests that the mortality benefit of PPCI over patient should then be transferred to the PPCI
thrombolysis is lost when the delay to PPCI centre for further evaluation and treatment as
reaches 114 minutes. However, other data necessary. In general, the implementation of a
suggest that a longer time delay may be simple protocol is likely to lead to better
acceptable, and moreover, that the other outcomes than any attempt to provide a more
benefits of PPCI, such as reduction of stroke and complex algorithm where the potential for
reinfarction, are not lost at this time period. confusion, or even error, is greater.
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7. A Guide to Implementing Primary Angioplasty 7
When setting up a service, it is important to normal day, and are then called back in for a
note that 120 minutes is an aspirational time to single PPCI procedure, then the European
treatment and is not a defined quality standard. Working Time Directive (EWTD) states that they
Based on the largest body of evidence to date, should have 11 hours continuous rest within any
PPCI may be the optimum strategy provided the 24 hour period. If the procedure ran from 4am
call-to-balloon time does not exceed 150 until 5am, then the staff would not be expected
minutes (i.e. the equivalent of a call-to-needle to work again until 4pm that day.
time of 30 minutes plus the 114 minutes during
The unpredictability of PPCI presentations, and
which PPCI is superior to thrombolysis).
the subsequent unpredictability of staff
At a national consensus meeting (September availability the following day, is a problem for all
2008), chaired by Professor Roger Boyle, there 24/7 PPCI centres but may be easier to manage
was clear national consensus that cardiac in a large centre with six catheter labs and a
networks should take the lead on developing large staff pool than in a centre with a single
their local 24/7 PPCI service (appendix 2). cardiac catheter lab. Some organisations (e.g.
West Midlands) have mandated that PCI centres
Does every PCI centre need to provide with a single catheter lab should not be set up
24/7 PPCI? as PPCI centres.
There are 69 NHS PCI centres in England; less It is important that any centre starting a primary
than one-third of these currently provide a 24/7 PCI programme understands that primary PCI is
PPCI service (4). The remaining centres provide different from other forms of PCI. Patients are
either no PPCI service or service during restricted sicker, complications are more frequent and
hours only (usually Monday to Friday 9-5). there is greater requirement for intra-aortic
Working on a rate of presentation of STEMI balloon pumping, mechanical variation etc. The
patients of 600 per million of the population per BCIS national PCI audit shows that the mortality
annum, and on the assumption that 22% of for primary PCI is around 4.6-4.8% (3). This is
patients present between midnight and 8am (5), approximately six times the mortality for NSTEMI
eighteen patients, on average, will present with PCI and more than twenty times the mortality
STEMI each night (midnight to 8am) in England. risk for elective PCI. It therefore seems sensible
To have all 69 cath labs in England staffed and that centres should only undertake primary PCI
available to perform PPCI, but waiting for just if they have 24-hour consultant cardiology
18 patients, would be hugely wasteful. availability (i.e. a consultant cardiology rota) to
Furthermore, PCI centres with a single cardiac manage patients following PPCI for STEMI. This
catheter lab may find their daytime work may be an issue with some non 24/7 PCI
schedule disrupted if they attempt to run a 24/7 centres.
PPCI service. If cardiac catheter lab staff work a
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8. 8 A Guide to Implementing Primary Angioplasty
Local factors and local geography will influence Should a non 24/7 PCI centre
how many PPCI centres are required. In most perform any PPCI?
densely populated areas of England, particularly
If we consider a cardiac network with one 24/7
if there are good transport links, one 24/7 PPCI
PCI centre and three PCI centres where the
centre should comfortably be able to serve a
cardiac catheter labs are non 24/7, then there
population of 1.5 - 2 million.
are three possible treatment scenarios for STEMI
patients: (appendix 3).
Does the size of a PCI centre affect
patient outcomes? 1.all STEMI patients are transferred directly to
the 24/7 centre. This would include any STEMI
This has been a contentious area for a number
patients who present directly to hospitals
of years. However, there is growing evidence
operating a non 24/7 PCI service.
that, in the setting of acute PCI for STEMI,
2.all STEMI patients are taken to the nearest
patient outcomes are better in centres with a
cardiac catheter lab. This means that a
larger volume of cases. In Germany, an analysis
proportion of patients would be taken for PPCI
of almost 28,000 patients compared outcomes
to the non 24/7 centres although the majority
in larger with smaller centres. There were no
(those presenting between 5pm and 8am
mortality differences for patients without a
Monday to Friday plus all weekend and Bank
myocardial infarction. Among those patients
Holiday presenters) would be taken to the
with an acute myocardial infarction, there was a
24/7 centre.
stepwise (and significant) reduction in mortality
3.all STEMI patients diagnosed by the
when moving from low volume to high volume
ambulance service are taken directly to the
centres. Centres in the top quartile for volume
24/7 centre but the small number who self-
(performing > 521 procedures per year) had a
present at the non 24/7 PCI centre would have
mortality of 2.78% compared with 3.97% for
their procedure locally provided the cardiac
centres performing 196-323 procedures per year
catheter lab was available.
and 4.41% for centres performing less than
166 procedures per year (6). All three options have their advantages and
disadvantages.
Analysis of the greater Paris PCI registry showed
similar results. Death rates for planned Option 1 is the simplest from the organisational
procedures were low and equivalent for small viewpoint; it provides a single route of referral
(<400 cases per year) and larger (>400 cases per (and single phone call) regardless of the time of
year) centres. For emergency procedures, day or day of the week. Furthermore, with the
however, the mortality rate was significantly advent of designated centres for major trauma
lower in the centres performing more than 400 and stroke disease, ambulance services are now
cases per year (6.75% vs 8.54%, p<0.05)(7). increasingly familiar with the concept of
bypassing a local hospital in order to deliver a
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9. A Guide to Implementing Primary Angioplasty 9
the ambulance is essential to allow the catheter
lab to prepare for the patient’s arrival. For out-
of-hours referrals, the pre-alert allows the staff
to travel to the hospital while the patient is
being transported. Thus a travel time of 60-90
minutes may be perfectly reasonable if this is the
time taken for all the catheter lab staff to travel
to the PCI centre and prepare for the patient’s
procedure. Provided the patient is taken directly
to the cardiac catheter lab (and not to Accident
patient to a specialist treatment centre. For this and Emergency or to Coronary Care), then it
reason, this is the preferred option in many areas should still be possible to meet the 120 minute
of the country (London, Newcastle, South Tees, call-to-balloon time. Door-to-balloon times may
West Yorkshire, and Greater Manchester). be affected by the size of the centre. During
normal working hours, door-to-balloon times
Option 2 is organisationally more complex but
may be shorter in a 24/7 centre with six cardiac
provides shorter transport times for weekday
catheter labs, four of which are engaged in PCI
daytime presenters. Some ambulance services
than in a non 24/7 centre with a single cardiac
prefer this option because their vehicles are less
catheter lab, particularly if the pre-alert time is
likely to be ‘off site’ during the day. However,
short. However, the balance between a shorter
many ambulance service Medical Directors say
transport time and a possibly longer door-to-
the uncertainty about what to do with a patient
balloon time will depend on local geography
at 8.30 am or 4.45 pm makes this system
and will need to be monitored closely, whatever
unwieldy. If this option is considered further, the
option is chosen.
non 24/7 centre must make an absolute
commitment to provide PPCI between the Regardless of where the PPCI procedures take
agreed hours every normal working day place, consideration should be given to those
regardless of other commitments. interventionists working at non 24/7 centres
contributing to the regional out-of-hours on-call
Option 3 is a variation of option 2; it has the
rota. There are 547 trained interventional
disadvantage that the 9-5 centre will see very
cardiologists in the UK (3). If out-of-hours PPCI is
few PPCI patients and will struggle to maintain
provided by 20-25 centres in the UK, then the
and develop skills.
on-call frequency could be as low as one night
When planning services, it is important to realise every three weeks. In practice, those at the non
that the travel time (in the ambulance) is only 24/7 centres will have other on-call
one component of the call-to-balloon time. The commitments and a full commitment to the rota
door-to-balloon time within the hospital is also is often not practical. Nevertheless, any
an important component. A ‘pre-alert’ call from contribution to the regional rota at the 24/7
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10. 10 A Guide to Implementing Primary Angioplasty
centre is generally welcomed. An appropriate
In West Yorkshire, PPCI commenced in
programmed activity (PA) calculation for the
Leeds in April 2005 and was later rolled
average amount of work done during on-call
out to the rest of the network. For each
should be made and this reimbursed from the patient, Leeds PCT paid the acute PCI
24/7 to the non 24/7 trust. This system already tariff. However, it no longer paid the MI
works well in some areas of the country and tariff and had to pay for a smaller number
helps to maintain and develop the skills of those of subsequent angiography and PCI
interventionists based at hospitals not providing procedures. This resulted in a saving to
a PPCI service. Leeds PCT of £750,000 in the first year.
For subsequent years, Leeds PCT reduced
Commissioning a PPCI service the SLA with Leeds Teaching Hospitals
NHS Trust for MI stays and subsequent
In some ways, commissioning of a PPCI service angiograms and the ‘savings’ were
differs from the commissioning of other new directed into other services (8).
clinical services. The procedure (PCI) is already
commissioned. Initial fears that commissioning a Indeed, the overall cost to commissioners of
PPCI service might lead to a substantial growth treating STEMI may fall following the
in total PCI numbers have been unfounded. In introduction of PPCI.
West Yorkshire, the introduction and roll-out of
PPCI to a population of around three million has Steps:
led to no increase in absolute PCI numbers, even
though PPCI now makes up 30% of the total 1. A network-wide discussion on the
PCI procedures. The reason for this is clear: number and location of centres that will
when thrombolysis was the standard treatment provide PPCI. This will be determined by
for STEMI patients, around 60-70% of geography, access to the centres and the
thrombolysed patients underwent angiography expected number of PPCI cases. These data
and/or PCI within six months of their initial should be available from the MINAP report (4).
presentation. Therefore, a policy of PPCI brings As noted earlier, this is unlikely to represent a
forward the PCI procedure to the time when the significant increase in PCI activity unless the pre-
patient has most to gain. existing level of intervention in the network was
particularly low. The service may be provided by
a mixture of 24/7 and non 24/7 PCI centres (see
The NIAP recommendation was simply that: above). If a PCI service serves a population of
“the procedures should be carried 500,000, and runs a 24/7 service, then it would
expect to see around 300 PPCI patients per
out in a centre with a sufficiently
annum. If the service is 9-5, 365 days per year,
high volume of cases to maintain then it would expect to treat around 58% of all
and develop skills.” PPCI patients in the area. If the service runs 9-5,
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11. A Guide to Implementing Primary Angioplasty 11
Monday to Friday, and is closed on Bank 2. Equality Impact Assessment. Local data
Holidays, then it would expect to perform PPCI and community intelligence will be required to
on approximately 40% of all STEMI patients assess the needs of the population and to
from its catchment area (i.e. 2-2.5 procedures provide equitable access for patients in rural
per week on average). areas will require longer ambulance journey
times. In areas with very long travel times to the
There is a risk of very patchy and fragmented
PPCI centre it may be appropriate to continue
services being developed. Smaller PCI centres
with a pre hospital thrombolysis service with the
(e.g. with two or three PCI operators) may feel
patients then transferring to a PCI centre for
threatened by the loss of some PCI activity to
angiography/PCI within a 24-hour timeframe (9).
their local 24/7 PCI centre and may feel obliged
to develop a 9-5 Monday to Friday PPCI service. 3. Setting up a 24/7 service. The 24/7 PCI
It is clearly important that the best interests of centre is likely to require additional non-medical
the patients are the primary concern. As noted staff (nursing staff, cardiac physiologists and
earlier, the mortality risk for STEMI patients radiographers) to cope with the increased
undergoing PCI is approximately six times the frequency of out-of-hours and weekend
mortality for non-STEMI PCI. These patients, working. With a high expectation of night
therefore, require access to a highly trained team working, there may be a knock-on effect to
in the catheter laboratory and in the coronary daytime staffing which needs to be considered.
care unit. If the procedure has been complicated, If the European Working Time Directive is
patients will require further specialist cardiology observed, then staff who work after midnight
input at any time of the day or night. For this will normally be allowed 11 hours’ rest prior to
reason, setting up a 9-5 PPCI service in a hospital returning to work. This will require a larger
without a consultant cardiology rota is not workforce and flexibility in the workforce. Under
recommended. When considering 9-5 centres, Payment by Results (PBR), there is no additional
the network, the commissioners and the funding for a PPCI procedure carried out at 3am
ambulance trust(s) need to balance carefully the compared to one at 3pm. As mentioned earlier,
benefits of shorter transfer times for a minority the increase in total PCI numbers may be very
of the patients presenting for PPCI against the modest. The PPCI centre, therefore, will incur
published data (outlined above) relating larger additional staffing costs which will not
procedural volumes to better patient outcomes. necessarily be balanced by extra income under
At present, there is no national recommendation PBR. Furthermore, some staff members may
on the minimum number of PPCI procedures have chosen cardiac catheter laboratory work
that should be performed by any centre. specifically because the daytime hours of
However, one advisory group has recommended working, with a low frequency of night-time
that only PCI centres performing more than 400 working, suited their domestic circumstances.
PCI procedures per annum should be
commissioned as primary PCI centres.
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12. 12 A Guide to Implementing Primary Angioplasty
The shift towards more frequent out-of-hours
working will require careful planning. If additional
staff are not employed, the delivery of daytime
cardiac catheter lab work (elective PCI,
angiography, pacing, EP etc) is likely to be
compromised.
4. Return to local hospital. One of the
advantages of a PPCI policy is that it shortens
hospital stay when compared to thrombolysis,
most patients being discharged on day three.
Depending on local arrangements, the patient
straightforward when there is a specific tariff for
may remain in the PCI centre and then be
rehabilitation which will usually be paid to the
discharged directly home; in other centres,
local hospital.
patients are transferred back to the local hospital
a few hours after the PPCI procedure. This is
6. Commissioning of the ambulance service.
sometimes referred to as ‘repatriation’ although
The ambulance service is the cornerstone to
the patient may well have been admitted directly
providing timely PPCI. As with stroke and serious
to the PCI centre via the ambulance service and
trauma, PPCI represents a major change in the
may never have been in the local hospital.
function of ambulance personnel who now play
5. Impact of PPCI on the DGH. A policy of a key role in diagnosis and in determining where
PPCI will have a major effect on the function of the patient will be best treated. Setting up the
the district general hospital (DGH) coronary care service, therefore, requires careful modelling of
unit (CCU). The emphasis on the DGH CCU will exactly what is required. In general, the
change from treating thrombolysed STEMI ambulance service is not required to make
patients to treating post-PPCI patients and additional emergency journeys with STEMI
NSTEACS patients. PPCI will also have an impact patients although the journeys will be longer if
on DGH income. In some centres, because of the patient bypasses the local hospital. Return of
the overall savings, PCTs have agreed to pay a the patient to the local hospital after PPCI may
PCI tariff to the PCI centre and an additional be a new service; in many instances, however,
‘short stay tariff’ to the DGH which takes the patients received thrombolysis at their local
patient soon after the PPCI procedure. In other hospital and were then transferred, by
centres, a ‘tariff split’ arrangement has been ambulance, to a PCI centre. In each network,
discussed with, for example, 80% of the PCI the amount of additional ambulance activity
tariff going to the PCI centre and 20% to the required will depend on the model of PPCI
hospital which takes the patient within 24 hours delivery chosen and on the pre-existing
of the procedure. This may become more arrangements for inter-hospital transfer of MI
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13. A Guide to Implementing Primary Angioplasty 13
patients and their families developing
misconceptions about heart attack as an
acute self limiting event rather than a marker of
a long term condition (10). They believe the
problem has been ‘fixed’. If the long term nature
of the condition is not appreciated by the
patient and their family, then the impact of
advice about behaviour modification such as
smoking cessation, weight loss, and regular
exercise may be reduced. The provision of
patients. Isochrone mapping of journey times information about prescribed medications,
may be a useful tool when calculating journey dietary recommendations and levels of physical
times to PPCI centres. exercise are important for patients and their
families. Additional support may be required for
7. Rehabilitation and longer term
elderly patients, those managing multiple co
management. Patients treated with primary
morbidities or those who have experienced
angioplasty have a shorter hospital stay
complications (eg cardiac arrest). Patients and
characterised by transfers across clinical settings.
families are not always certain of where hospital
An unintended consequence of this is the
care ‘finishes’ and community care ‘begins’ so
reduction in time available for health
information about who they may contact if they
professionals to provide the patient and family
experience difficulties during early recovery is
with health education and psychological
valuable.
support. To ensure that patients do not ‘fall
through gaps’ clear communication is required
between acute services and the primary care
trust. The involvement of cardiac rehabilitation
teams during the early planning phase of
services is recommended. Cardiac rehabilitation
services may require additional resources with
emphasis upon service delivery in a primary care
rather than acute care setting. Effective
discharge planning and timely referral for cardiac
rehabilitation supports early recovery and
secondary prevention.
8. Impact of families and carers. Another
unintended consequence of PPCI is that the
short hospital stay may contribute towards
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14. 14 A Guide to Implementing Primary Angioplasty
Help with implementation Summary
NHS Improvement - Heart Improvement The implementation of PPCI as the default
Programme is providing support for the treatment nationally for patients with STEMI cuts
implementation of PPCI as stated in ‘Treatment across many boundaries. Those cardiac networks
of Heart Attack National Guidance’. This support who have not yet implemented PPCI can learn a
is in the form of a series of themed national great deal from the areas of the country where
meetings and bespoke support for cardiac the service is already up and running. The
networks and SHAs from the national clinical experience of the North East of England, one of
lead and national improvement lead for the NIAP pilot sites, summarises the major
reperfusion. Up to date information, resources issues. They concluded that the implementation
and case studies are available on a dedicated of PPCI across the region revolved around
web page on the NHS Improvement website. finding acceptable answers to five key questions:
Further information and contact details
1. What are the patient pathways associated
can be found on the website at:
with the implementation of PPCI?
www.improvement.nhs.uk/heart/reperfusion
2. What is the appropriate Payment by Results
structure for funding these pathways?
3. What are the additional ambulance services
required to support these pathways?
4. What is the knock-on impact to non-PPCI
units of moving to PPCI?
5. What are the commissioning impacts for all
PCTs and acute trusts in the region, including
the one-off consequences of commissioning
change and the sustained revenue
consequences and impact on system-wide
viability?
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15. A Guide to Implementing Primary Angioplasty 15
Appendix 1: Key Studies in Primary PCI
1. Primary PCI versus intravenous additional ambulance journey and a delay in
thrombolytic therapy for acute myocardial starting the reperfusion treatment. The median
infarction: a quantitative review of 23 time interval from randomization to the start of
randomised trials. treatment was 20 minutes (range 15-30
The Lancet 2003;361:13-20 minutes) for those patients in community
Keeley E, Boura J, Grines C. hospitals treated with thrombolysis and 90
minutes (range 74-108 minutes) for those
In this metanalysis of 23 randomised trials,
patients transported to a PPCI centre.
involving 7,739 patients, primary PCI was
associated with significant reduction in death
3. Hospital Delays in Reperfusion for ST-
(7% vs 9%), non-fatal re-infarction (3% vs 7%)
Elevation Myocardial Infarction: Implications
and stroke (1% vs 2%). However, the studies
When Selecting a Reperfusion Strategy.
included in this metanalysis relate to patients
Pinto DS, Kirtane AJ, Brahmajee K, et al.
presenting to PCI centres. In the UK, many
Circulation 2006;114:2019-2025.
patients present acutely to non-PCI hospitals.
In this observational study, the inherent delay in
2. A comparison of coronary angioplasty PPCI was calculated by subtracting door-to-
with fibrinolytic therapy in acute needle times from door-to-balloon times in a
myocardial infarction. very large registry of 192,000 MI patients. After
Anderson HR, Nielsen TT, Rasmussen K, et al correction for patient and hospital-based factors,
N Engl J Med 2003;349:733-742 the timepoint at which the odds of death with
PCI were equal to those for thrombolysis
In the studies included in the metanalysis
occurred when the PCI delay (i.e. the difference
described above (Keeley et al), patients
between door-to-needle and door-to-balloon
presenting to a PCI-capable hospital were
times) was 114 minutes.
randomised to either PPCI or thrombolysis. In
this study (DANAMI-2), 1129 patients presenting
to non-PCI centres were randomised to either
immediate thrombolysis (at the community
hospital) or to transportation by ambulance to a
PCI centre for primary PCI. The primary end-
point (death, re-infarction or disabling stroke)
was significantly lower in the PPCI group than in
the thrombolysis group (8.5% vs 14.2%,
p<0.002) even though the PPCI group had an
www.improvement.nhs.uk/heart
16. 16 A Guide to Implementing Primary Angioplasty
Appendix 2: National PCI Consensus Meeting
A national PCI consensus meeting was held by 2. Workforce
NHS Improvement on 24th September 2008. Workforce issues for all catheter lab staff were
Invited to the meeting were cardiac network discussed. Centres should observe the European
representatives and interventional cardiologists Working Time Directive with regard to rest for
from large (surgical) centres, from PCI centres on-call staff who have been working during the
without on-site surgical cover and from DGHs night. For consultant staff, this means altering
planning to set up PCI services. Speakers job plans so that the consultant has no fixed
included Dr Roger Boyle (National Director for commitments after a night on-call. It was
Heart and Stroke), Dr Huon Gray (Author of the acknowledged that this may have adverse
NIAP report) and Dr Mark de Belder (President of effects on catheter lab scheduling and
the British Cardiovascular Intervention Society). productivity.
The discussion centred on the current status of
Possible destabilisation and recruitment issues
PCI delivery in the UK, requirements for new
were discussed. This could be destabilisation of
centres to deliver more PCI, the role of cardiac
the DGH with deskilling of CCU staff if the care
networks and issues around measuring and
of STEMI patients transfers from a DGH to a
reporting quality.
24/7 PCI centre. On the other hand, 24/7
The main areas of agreement working may cause some staff to move away
consensus were: from the 24/7 PCI centre to a non-24/7 PCI
centre.
1. Networks
Agreement was reached that networks are the 3. British Cardiovascular Intervention
correct building blocks for planning PCI services. Society (BCIS)
Cardiac networks are patient focused and The majority agreed that the BCIS peer review
provide a forum to arrive at a clinical consensus scheme was still required and BCIS had a role in
on patient care. They are able to discuss the the accreditation of new centres and in setting,
whole patient pathway across boundaries able and publishing, agreed standards.
to take a strategic view and influence trusts.
4. Measuring and reporting quality
There was also agreement that cross boundary
There was general agreement that quality in PCI
working is required to deliver equitable services
is difficult to measure and that more robust
for patients. Cross boundary working was
outcome data are required including evidence
especially pertinent for working with ambulance
relating volume of activity to outcomes.
services.
www.improvement.nhs.uk/heart
17. A Guide to Implementing Primary Angioplasty 17
Appendix 3: Treatment Options for STEMI
Option 1
Patient with STEMI
Call 999 GP Self presents in A&E
24/7 heart
attack centre
Option 2
Patient with STEMI
Call 999 GP Self presents in A&E
Local hospital Local hospital
Out of hours 24/7 heart Out of hours
Weekends attack centre Weekends
Bank holidays Bank holidays
Option 3
Patient with STEMI
Call 999 GP Self presents in A&E
24/7 heart When catheter labs are unavailable
attack centre
Local hospital
www.improvement.nhs.uk/heart
18. 18 A Guide to Implementing Primary Angioplasty
References
1. Department of Health (2008) Treatment of Heart Attack National Guidance –
Final Report of the National Angioplasty Project (NIAP)
2. Darzi A (2008) High Quality Care for All
3. British Cardiovascular Intervention Society (2007) Audit report
www.bcis.org.uk/resources/audit
4. Royal College of Physicians (2008) Myocardial Ischaemia National Audit Report (MINAP)
How the NHS manages heart attacks
5. Primary percutaneous coronary intervention for acute ST segment elevation
myocardial infarction - first year’s experience of a tertiary referral centre in the UK.
Dorsch MF, Blackman DJ, Greenwood J, et al
Clinical Medicine 2008;8:259-263.
6. Volume-outcome relation for contemporary percutaneous coronary interventions (PCI) in daily
clinical practice: is it limited to high-risk patients? Results from the Registry of Percutaneous
Coronary Interventions of the Arbeitsgemeinschaft Leitende Kardiologische
Krankenhausarzte (ALKK).
Zahn R, Gottwik M, Hochadel M, et al.
Heart 2008;94:329-335
7. Is the volume-outcome relation still an issue in the era of PCI with systematic stenting?
Results of the greater Paris area PCI registry.
Spaulding C, Morice MC, Lancelin B, et al.
European Heart Journal 2006;27:1054-1060
8. West Yorkshire Cardiovascular Network (2008) – personal communication
9. ‘Management of acute myocardial infarction in patients presenting with persistent ST elevation’
European Society of Cardiology Guidelines Van de Werf F, Bax J, Betriu, et al. European Heart
Journal (2008) 29,2909-2945
10.Primary angioplasty for heart attack: mismatch between expectation and reality.
Astin F, Closs SJ, McLenachan JM, et al
Journal of Advanced Nursing 2008;65:72-83
Authors
Dr J M McLenachan, National Clinical Lead, Reperfusion, NHS Improvement,
Consultant Cardiologist, Leeds General Infirmary
Carol Marley, National Improvement Lead, Reperfusion, NHS Improvement
Sheelagh Machin, Director, Heart, NHS Improvement
April 2009
www.improvement.nhs.uk/heart